Trial of NanoPac Intratumoral Injection in Lung Cancer

Phase 2

Completed

• Conditions: Neoplasm of Lung; Lung Cancer; Lung Cancer, Nonsmall Cell; Lung Cancer, Small Cell
• Interventions: Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

• Registration Number: NCT04314895
• Lead Sponsor: NanOlogy, LLC

Brief Summary

This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.

Detailed Description

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2021-04-14
• Primary Completion: 2023-09-26
• Study Completion: 2023-09-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Signed informed consent;

• Age ≥18 years and able to tolerate the EBUS-TBNI procedure;

• Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease;

• At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI;

• Subject is not a candidate for surgery;

• Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC;

• Performance Status (ECOG) 0-2 at study entry;

• Life expectancy of at least 6 months;

• Adequate marrow, liver, and renal function at study entry;

  • ANC ≥ 1.5 x 109/L;
  • Hemoglobin ≥ 9.0 grams/dL;
  • Platelets ≥ 75 x 109/L;
  • Total bilirubin ≤ 1.5x institutional ULN;
  • AST/ ALT ≤ 2.5x institutional ULN;
  • Creatinine ≤ 1.5x institutional ULN;

• Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*

Exclusion Criteria

• Significant cardiac disease (Class III or IV per New York Heart Association guidelines);
• Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C);
• Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded)
• Known hypersensitivity to study agent;
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NanoPac	NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension	Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events	Day 1 to Week 24 (6 Months)

Secondary Outcome Measures

Name	Time	Method
Overall survival	Day 1 and Week 52	As determined by survival time following first NanoPac injection
Progression free survival	Day 1 and Weeks 24 and 52	Progression free survival as assessed using RECIST v1.1
Change in tumor dimensions	Day 1 and Weeks 12, 24, 38, and 52	As determined by CT scan imaging
Concentration of paclitaxel in the systemic circulation post-injection	Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24

Trial Locations

Locations (4)

University of Florida Health; 🇺🇸 Gainesville, Florida, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Parkview Research Institute; 🇺🇸 Fort Wayne, Indiana, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States